A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The response to treatment
研究概览
简要总结
To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard;
- •ECOG score 0-1;
- •HCC BCLC grading 0, A, B, C;
- •Child-Pugh score prior to therapy A and B;
- •As judged by investigators, the patient can comply with the study protocol;
- •Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form.
排除标准
- •HCC BCLC grading D;
- •Child-Pugh score prior to therapy C.
结局指标
主要结局
The response to treatment
时间窗: 1 month after therapy
Viable tumors were assessed by MRI according to EASL criteria. The enhanced and non-enhanced areas represent viable and necrotic tumors. At least 2 radiologists evaluate the approximate viable tumor residues (%) of total tumor volume (Total tumor volume was the sum of viable and necrotic volume). The response to treatment is defined by the Viable Tumor Residues (%) as below: complete response (CR), no obvious viable residuals; near complete response (NCR), viable residuals \<10%; partial response (PR), viable residuals \>10% but \< 50%; stable disease (SD), viable tumor residuals between \>50% but ≤100%; and progressive disease (PD), viable tumors \> 100%.
次要结局
- Lifetime (months)(6 months once after therapy)